Baclofen 25mg/5ml Oral Susp 120ml
It is used to treat spasms in patients with MS (multiple sclerosis) or spinal cord problems.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Skeletal Muscle Relaxant
Pharmacologic Class
Centrally Acting GABA-B Receptor Agonist
Pregnancy Category
Category C
FDA Approved
Mar 1977
DEA Schedule
Not Controlled
Overview
What is this medicine?
Baclofen is a medication used to relax muscles and reduce muscle stiffness (spasticity) caused by conditions like multiple sclerosis or spinal cord injury. It works by acting on your nervous system to calm overactive muscle reflexes.
How to Use This Medicine
Taking Your Medication Correctly
To ensure you get the most out of your medication, follow your doctor's instructions carefully. Read all the information provided with your medication and follow the instructions closely. When measuring liquid doses, use the measuring device that comes with the medication. If one is not provided, ask your pharmacist for a suitable measuring device. Avoid using household teaspoons or tablespoons, as this can lead to an incorrect dose.
Before using the medication, shake the container well. If you have a feeding tube, check with your doctor or pharmacist to see if your specific brand of medication can be used with it. If it can, take the medication as directed and flush the feeding tube afterward.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, avoiding bathrooms. After opening, discard any unused portion after 2 months. Keep all medications in a safe location, out of the reach of children and pets.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take extra doses to make up for a missed one.
To ensure you get the most out of your medication, follow your doctor's instructions carefully. Read all the information provided with your medication and follow the instructions closely. When measuring liquid doses, use the measuring device that comes with the medication. If one is not provided, ask your pharmacist for a suitable measuring device. Avoid using household teaspoons or tablespoons, as this can lead to an incorrect dose.
Before using the medication, shake the container well. If you have a feeding tube, check with your doctor or pharmacist to see if your specific brand of medication can be used with it. If it can, take the medication as directed and flush the feeding tube afterward.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, avoiding bathrooms. After opening, discard any unused portion after 2 months. Keep all medications in a safe location, out of the reach of children and pets.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take extra doses to make up for a missed one.
Lifestyle & Tips
- Avoid alcohol and other medications that cause drowsiness (e.g., sedatives, tranquilizers, opioids) as they can increase the sedative effects of baclofen.
- Be cautious when driving or operating machinery until you know how baclofen affects you, as it can cause drowsiness or dizziness.
- Do not stop taking baclofen suddenly, especially if you have been on it for a long time or at high doses. This can lead to serious withdrawal symptoms. Your doctor will tell you how to slowly reduce your dose.
- Take baclofen with food or milk if it upsets your stomach.
- Store the oral suspension at room temperature and shake well before each use.
Available Forms & Alternatives
Available Strengths:
- Baclofen 10mg Tablets
- Baclofen 20mg Tablets
- Baclofen 40mg/20ml Inj, 20ml
- Baclofen 5mg Tablets
- Baclofen 20mg/20ml Inj 20ml
- Baclofen 10mg/20 Inj, 20ml
- Baclofen 5mg/5ml Solution
- Baclofen 50mcg/ml Pf Syr, 1ml
- Baclofen 25mg/5ml Oral Susp 300ml
- Baclofen 25mg/5ml Oral Susp 120ml
- Baclofen 15mg Tablets
- Baclofen 25mg/5ml Oral Susp 250ml
- Baclofen 2000mcg Inj Refill Kit
Dosing & Administration
Adult Dosing
Standard Dose:
Initial 5 mg three times daily, titrate slowly
Dose Range:
5 - 80 mg
Condition-Specific Dosing:
spasticity:
Initial 5 mg three times daily for 3 days, then 10 mg three times daily for 3 days, then 15 mg three times daily for 3 days, then 20 mg three times daily for 3 days. Further increases may be made cautiously up to a maximum of 80 mg/day (20 mg four times daily).
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Limited data, often off-label. Initial 0.3 mg/kg/day in 4 divided doses. Titrate slowly over 2-4 weeks to 1.5-2 mg/kg/day. Max 40 mg/day for children <8 years; max 60 mg/day for children >8 years.
Adolescent:
Similar to adult dosing, but start low and titrate slowly based on response and tolerability.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment, but monitor for increased adverse effects.
Moderate:
Consider dose reduction (e.g., 5 mg once daily or every other day) and titrate cautiously.
Severe:
Initial 5 mg once daily. Titrate very cautiously. Avoid in end-stage renal disease unless benefits clearly outweigh risks.
Dialysis:
Baclofen is dialyzable. Administer dose after dialysis. Significant dose reduction required, e.g., 5 mg once daily or every other day.
Hepatic Impairment:
Mild:
No specific adjustment needed.
Moderate:
No specific adjustment needed, as baclofen is minimally metabolized by the liver.
Severe:
No specific adjustment needed, as baclofen is minimally metabolized by the liver.
Pharmacology
Mechanism of Action
Baclofen is a centrally acting skeletal muscle relaxant. It acts as an agonist at GABA-B receptors, primarily at the spinal cord level. This action inhibits both monosynaptic and polysynaptic reflexes, leading to a reduction in muscle spasticity. The precise mechanism of action in reducing spasticity is thought to involve hyperpolarization of afferent terminals and inhibition of both excitatory and inhibitory neurotransmission.
Pharmacokinetics
Absorption:
Bioavailability:
70-85%
Tmax:
2-3 hours
FoodEffect:
Food may delay the time to peak concentration (Tmax) but does not significantly affect the extent of absorption (AUC).
Distribution:
Vd:
0.7 L/kg
ProteinBinding:
Approximately 30%
CnssPenetration:
Limited (though it acts centrally, it does not readily cross the blood-brain barrier compared to some other CNS agents)
Elimination:
HalfLife:
3-4 hours
Clearance:
Not available
ExcretionRoute:
Primarily renal (70-80% excreted unchanged in urine)
Unchanged:
70-80%
Pharmacodynamics
OnsetOfAction:
1-2 hours
PeakEffect:
2-4 hours
DurationOfAction:
4-6 hours
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Severe dizziness or fainting
Confusion
New or worsening mental, mood, or behavioral changes
Hallucinations (seeing or hearing things that are not there)
Seizures
Changes in balance or coordination
Changes in vision
Chest pain
Muscle pain or weakness
Muscle stiffness
Abnormal burning, numbness, or tingling sensations
Breathing difficulties, slow breathing, or shallow breathing
Urination problems, such as:
+ Inability to pass urine
+ Changes in urine output
+ Changes in urination frequency
+ Blood in the urine
Swelling in the arms or legs
Trouble controlling body movements, twitching, or changes in balance
Difficulty swallowing or speaking
Uncontrolled eye movements
Abnormal heartbeat
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people may not experience any side effects or may only have mild ones. If you are bothered by any of the following side effects or if they do not go away, contact your doctor or seek medical help:
Dizziness, drowsiness, fatigue, or weakness
Sleep disturbances
Upset stomach or vomiting
Headache
Constipation
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Severe dizziness or fainting
Confusion
New or worsening mental, mood, or behavioral changes
Hallucinations (seeing or hearing things that are not there)
Seizures
Changes in balance or coordination
Changes in vision
Chest pain
Muscle pain or weakness
Muscle stiffness
Abnormal burning, numbness, or tingling sensations
Breathing difficulties, slow breathing, or shallow breathing
Urination problems, such as:
+ Inability to pass urine
+ Changes in urine output
+ Changes in urination frequency
+ Blood in the urine
Swelling in the arms or legs
Trouble controlling body movements, twitching, or changes in balance
Difficulty swallowing or speaking
Uncontrolled eye movements
Abnormal heartbeat
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people may not experience any side effects or may only have mild ones. If you are bothered by any of the following side effects or if they do not go away, contact your doctor or seek medical help:
Dizziness, drowsiness, fatigue, or weakness
Sleep disturbances
Upset stomach or vomiting
Headache
Constipation
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Severe drowsiness or sedation
- Confusion or hallucinations
- Difficulty breathing
- Unusual muscle weakness
- Seizures (especially if stopping abruptly)
- Increased spasticity (if stopping abruptly)
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins.
* Any existing health problems, as this medication may interact with other drugs or health conditions.
To ensure your safety, it is crucial to verify that this medication can be taken with all your current medications and health conditions. Always consult your doctor before starting, stopping, or changing the dose of any medication.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins.
* Any existing health problems, as this medication may interact with other drugs or health conditions.
To ensure your safety, it is crucial to verify that this medication can be taken with all your current medications and health conditions. Always consult your doctor before starting, stopping, or changing the dose of any medication.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Before operating a vehicle or engaging in any activity that requires your full attention, wait until you understand how this medication affects you. It is also crucial to discuss the use of alcohol, marijuana, or other forms of cannabis, as well as prescription or over-the-counter (OTC) medications that may cause drowsiness, with your doctor beforehand.
Do not abruptly discontinue the use of this medication, as this may increase your risk of experiencing side effects. These side effects can include hallucinations (perceiving things that are not present), seizures, high fever, muscle stiffness, and confusion. In rare cases, sudden withdrawal from this medication can lead to organ damage and even death. If you need to stop taking this medication, it is vital to do so gradually, under the guidance of your doctor. If you experience any new or worsening symptoms, consult your doctor promptly.
When administering this medication to children, exercise caution, as they may be at a higher risk of developing certain side effects.
If you are pregnant, planning to become pregnant, or are breastfeeding, it is crucial to discuss the potential benefits and risks of this medication with your doctor. Taking this medication during pregnancy may cause withdrawal symptoms in the newborn.
Before operating a vehicle or engaging in any activity that requires your full attention, wait until you understand how this medication affects you. It is also crucial to discuss the use of alcohol, marijuana, or other forms of cannabis, as well as prescription or over-the-counter (OTC) medications that may cause drowsiness, with your doctor beforehand.
Do not abruptly discontinue the use of this medication, as this may increase your risk of experiencing side effects. These side effects can include hallucinations (perceiving things that are not present), seizures, high fever, muscle stiffness, and confusion. In rare cases, sudden withdrawal from this medication can lead to organ damage and even death. If you need to stop taking this medication, it is vital to do so gradually, under the guidance of your doctor. If you experience any new or worsening symptoms, consult your doctor promptly.
When administering this medication to children, exercise caution, as they may be at a higher risk of developing certain side effects.
If you are pregnant, planning to become pregnant, or are breastfeeding, it is crucial to discuss the potential benefits and risks of this medication with your doctor. Taking this medication during pregnancy may cause withdrawal symptoms in the newborn.
Overdose Information
Overdose Symptoms:
- Severe muscle weakness
- Vomiting
- Drowsiness progressing to coma
- Respiratory depression (slow, shallow breathing)
- Seizures
- Hypotension (low blood pressure)
- Hypothermia
- Loss of reflexes
What to Do:
Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment is supportive, including maintaining airway, breathing, and circulation. Gastric lavage may be considered if ingestion was recent. Hemodialysis may be useful in severe cases, especially with renal impairment.
Drug Interactions
Major Interactions
Moderate Interactions
- Antihypertensives: May enhance hypotensive effects.
- Lithium: Exacerbation of hyperkinetic symptoms has been reported.
- Tricyclic antidepressants: May potentiate the muscle relaxant effect of baclofen, leading to increased sedation.
- Gabapentin: Increased risk of CNS depression (drowsiness, dizziness, respiratory depression).
Monitoring
Baseline Monitoring
Assessment of spasticity severity and functional limitations
Rationale: To establish baseline for evaluating treatment efficacy.
Timing: Prior to initiation of therapy
Renal function (serum creatinine, eGFR)
Rationale: Baclofen is primarily renally excreted; dose adjustment may be necessary in renal impairment.
Timing: Prior to initiation of therapy
Routine Monitoring
Spasticity reduction and functional improvement
Frequency: Regularly during dose titration and periodically thereafter
Target: Individualized based on patient goals and tolerability
Action Threshold: Lack of efficacy or intolerable side effects warrant dose adjustment or discontinuation.
Adverse effects (e.g., sedation, dizziness, weakness, nausea, confusion)
Frequency: Regularly, especially during dose titration
Target: Minimal to no adverse effects
Action Threshold: Significant or persistent adverse effects require dose reduction or discontinuation.
Renal function (serum creatinine, eGFR)
Frequency: Periodically, especially in patients with pre-existing renal impairment or elderly patients.
Target: Stable renal function
Action Threshold: Deterioration in renal function may necessitate dose adjustment.
Symptom Monitoring
- Sedation
- Dizziness
- Weakness
- Nausea
- Confusion
- Fatigue
- Headache
- Insomnia
- Hypotension
- Urinary frequency/retention
- Withdrawal symptoms (if abruptly stopped): increased spasticity, hallucinations, seizures, hyperthermia, rebound spasticity, rhabdomyolysis
Special Patient Groups
Pregnancy
Baclofen is Pregnancy Category C. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown adverse effects at doses higher than human therapeutic doses.
Trimester-Specific Risks:
First Trimester:
Potential for developmental abnormalities, though human data are limited and conflicting.
Second Trimester:
Limited data, generally considered safer than first trimester but still category C.
Third Trimester:
Potential for neonatal withdrawal symptoms if used close to term, including seizures, hypertonia, and tremors.
Lactation
Baclofen is excreted in breast milk in small amounts. The American Academy of Pediatrics considers baclofen to be compatible with breastfeeding. Monitor the infant for signs of sedation (e.g., unusual drowsiness, poor feeding).
Infant Risk:
Low risk, but monitor for sedation.
Pediatric Use
Safety and efficacy in children under 12 years of age have not been fully established by the FDA for spasticity of cerebral origin. Use in children is often off-label and requires careful dose titration and monitoring due to potential for increased sensitivity to adverse effects.
Geriatric Use
Elderly patients may be more sensitive to the CNS depressant effects of baclofen (e.g., sedation, dizziness, confusion) and are more likely to have impaired renal function. Start with lower doses and titrate slowly, monitoring closely for adverse effects and renal function.
Clinical Information
Clinical Pearls
- Baclofen should never be discontinued abruptly, as this can lead to severe withdrawal symptoms including hallucinations, seizures, rebound spasticity, and rhabdomyolysis. Doses should be tapered slowly over 1-2 weeks.
- Oral baclofen suspension (25mg/5ml) is particularly useful for patients who have difficulty swallowing tablets or require precise dose adjustments.
- Patients should be advised to avoid activities requiring mental alertness (e.g., driving, operating machinery) until they know how baclofen affects them.
- Concomitant use with other CNS depressants (e.g., alcohol, benzodiazepines, opioids) should be avoided or used with extreme caution due to additive sedative effects.
- Monitor for signs of overdose, especially in patients with renal impairment, as baclofen accumulates in the body.
Alternative Therapies
- Tizanidine (another alpha-2 adrenergic agonist muscle relaxant)
- Cyclobenzaprine (tricyclic antidepressant derivative muscle relaxant)
- Dantrolene (direct-acting skeletal muscle relaxant)
- Botulinum toxin injections (for focal spasticity)
- Physical therapy and occupational therapy
- Benzodiazepines (e.g., diazepam, clonazepam - for short-term use due to dependence risk)
- Intrathecal baclofen pump (for severe, refractory spasticity)
Cost & Coverage
Average Cost:
Not available Not available
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (Generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.